Scientist/Senior Scientist – Production & QC

Bit bio

Closing Date: 06/01/2023

Apply Now https://boards.eu.greenhouse.io/bitbio/jobs/4061195101

Scientist/Senior Scientist – Production & QC

at Bit Bio Cambridge, UK

bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.

As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.

Location: Babraham Research Campus, Cambridge

Type: Full time, permanent

Start: Immediate

Lab based position

Your role in our team:

We are looking for an experienced Scientist/Senior Scientist to work on the scale-up, automation and manufacture of a wide range of iPSCs and iPSC-derived cell types. Working closely with the team lead and/or Director of Manufacturing, you will maximise production efficiency, optimise production workflows, monitor stock levels and deliver operational excellence.

The Scientist/Senior Scientist will work closely with the R&D, Process Development, Automation, Quality, Logistics and Commercial teams to deliver a quality product to market. As such, there is a requirement to be diplomatic, collaborative, customer focused, change agile, comfortable in leading and adapting to changing priorities in a rapidly growing business.

Your key responsibilities will include:

Leading on the tech transfer process into production & overseeing engineering runs of new cell types entering production from MSAT.

Leading production runs on a rapidly growing portfolio of iPSC-derived cell types.

Working with MSAT to optimise the critical aspects of production protocols for new cell types, including scale-up of culture conditions, cryopreservation, thawing & QC.

Producing and maintaining SOPs for the production of new cell types as well as lead on route cause analysis of failed production runs.

Supervision of junior members of the team, motivating and developing them to achieve high levels of performance and productivity. Overseeing development and training activities as well as coaching individuals to perform their roles effectively.

Work independently to carry out all core accountabilities of the role as well as promote a proactive, continual improvement culture to maintain high standards of service and good practice.

Contribute to developments in laboratory organisation and contribute to maintaining the core cultural aspects of the company.

...in addition for the Senior Scientist role you will:

Establish, monitor and report key performance data to the Director of Manufacturing e.g. production schedules, group capacity, stock levels, progress against targets and failure rates.

Actively engage with bit.bio's Project & Product Management teams to provide timelines on the development and execution of manufacturing processes.

Lead a team of Scientists with responsibility for their day to day activities and career development.

Coordinate time, resources and cross-team functionality required for the scheduling & execution of production runs.

Lead the integration of technologies and/or infrastructure to support the continued development of the production team.

You…

Have a Bachelor’s or Master’s degree in a relevant field of biological science with a PhD being desirable or equivalent.

Demonstrable experience in a relevant industry or scientific organisation.

Are process oriented and experienced in developing, optimising & implementing workflows, protocols, procedures and resources in a quality management environment.

Are a motivated scientist demonstrating the highest scientific rigour, operational skill and work standards.

Have demonstrable experience in growing and leading a high-performing team of scientists.

Are humble - sincere and secure - accepts own mistakes - prioritises team over personal goals.

Are hungry - driven and proactive - goes above and beyond the call of duty to achieve company results.

Are smart - astute and persuasive - uses emotional intelligence to lead and inspire colleagues.

With essential experience in…

Human induced pluripotent stem cell biology, characterisation and culture systems.

Manufacturing of cell-based products, process development & commercialisation of iPSC-derived cell types.

Team leadership and managing internal & external stakeholder relationships.

Experience in process tech transfer / transfer to GMP manufacture.

Experience of working in a regulated environment to GLP, GMP or similar.

Developing operational infrastructure, capacity planning and implementing key performance indicators for manufacturing processes.

Excellent time management, organisational and communication skills.

Financial management, calculating cost of goods, budget control and reporting.

…and possibly…

Expertise in continuous improvement and its implementation (e.g. LEAN, 5S).

Have experience in cell culture automation.

Direct industrial experience working with biologics, gene and / or cell therapy process development & optimisation.

Have worked in large cell bank organisations.

Have experience of quality risk management.

More reasons to join us:

bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.

We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.

Creativity and open minds are encouraged for everyone to contribute to the success of the company.

For information on how we will manage your data please see our Candidate Privacy Notice - https://www.bit.bio/candidate-privacy-notice

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